BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-O S/5 CRITICAL CARE SOFTWARE LICENSE L-ICU01A

    MDR report key: 445008 · Received February 13, 2003

    Report

    Report Number
    9610105-2003-00001
    Event Type
    Malfunction
    Date Received
    February 13, 2003
    Date of Event
    January 10, 2003
    Report Date
    February 13, 2003
    Manufacturer
    DATEX-OHMEDA DIVISION, INSTRUMENTARIUM CORP.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAS AN ATRIOVENTRICULAR BLOCK < 30 BPM(=AV-BLOCK) ASSISTED BY A PACEMAKER SET AS A WATCHER AT 35 BPM. THE MONITOR CALCULATED A CARDIAC RATE AT 105 BPM. THE USER EXPECTED THE MONITOR TO BRADYCARDIA ALARM (LIMIT AT 40) ACCORDING TO THE HOSPITAL, THE PACEMAKER WAS NOT IN USE DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-O S/5 CRITICAL CARE SOFTWARE LICENSE L-ICU01A DATEX-OHMEDA MULTIPARAMETER PATIENT MONITOR DSI DATEX-OHMEDA DIVISION, INSTRUMENTARIUM CORP. L-ICU01A *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other HEMODYNAMIC MODULE M-ESTPR S/N 4378439, MONITOR